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Saturday, January 15, 2022 5:09:30 PM
Are you really saying the FDA regulates the ability for NWBO to sell DCVax-L in the UK?
wow it amazes me that you did not know this but NWBO is an American corporation regulated by the American FDA first and foremost
For pharmaceutical companies operating in the United States, the U.S. Food and Drug Administration (FDA) regulates the drug approval process and oversees the expanded access pathway for patients with an unmet medical need to access investigational drugs under 21CFR 312 Subpart 1.
https://mytomorrows.com/en/blog/expanded-access-program-compassionate-use-frameworks-europe
and of course, like I said they need the MHRA to approve the compassionate sales as well
However, pharma companies seeking access to the European market face dealing with the European Medicines Agency (EMA) for drug approvals, as well as navigating a myriad of country-specific regulations on accessing investigational drugs.
Do you really think that the FDA after seeing the ineffective DCVAXL data really would not step in while NWBO steps up production selling DCVAX L in the UK?
Do you really think the relation between the US and the UK is that bad the FDA would let its British colleagues in the dark?
And do you really think the MHRA would let a situation exist where an American company can keep selling a high-impact biological drug with life-threatening consequences in the UK without any knowledge of the opinion of its counterpart the FDA?
The UK, not banana island you know.
Wow you are either incredibly naive or really, really dont want patients to benift.
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